Xencor to Present New Clinical Data from the Phase 1 Study of Plamotamab in Relapsed or Refractory Non-Hodgkin’s Lymphoma at the American Society of Hematology Annual Meeting
Xencor, Inc. (NASDAQ: XNCR) announced it will present clinical data from its Phase 1 study of plamotamab, a CD20 x CD3 bispecific antibody, at the ASH Annual Meeting on December 12, 2022. Plamotamab showed encouraging results in patients with relapsed non-Hodgkin’s lymphoma. The study indicated a 47.4% overall response rate (ORR) in patients with diffuse large B-cell lymphoma and a 100% ORR in those with follicular lymphoma. Despite common adverse events like cytokine release syndrome, the treatment was generally well tolerated. This marks a significant step in Xencor's development of targeted cancer therapies.
- Plamotamab demonstrated a 47.4% overall response rate in DLBCL and 100% in follicular lymphoma.
- The treatment was deemed generally well tolerated with manageable adverse events.
- Active recruitment in Phase 1 expansion cohorts with promising interim data.
- Cytokine release syndrome occurred in 72.2% of patients, indicating safety concerns.
- Adverse events led to treatment discontinuation in 13.9% of patients.
“Plamotamab continues to be generally well tolerated and demonstrates encouraging clinical activity in our recommended intravenous dosing regimen,” said
Expansion cohorts in the Phase 1 study are actively recruiting patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) and are dosing using the proposed intravenous recommended Phase 2 regimen to evaluate the safety and efficacy of plamotamab monotherapy. The recommended dose (RD) was previously identified as an intravenous, 50 mg flat dose every two weeks after step-up dosing during the first two cycles of treatment. Subcutaneous administration of plamotamab is currently being incorporated into the study.
Key Highlights from the Abstract
The accepted abstract with data from the study is accessible through the ASH website. Updated results will be shared at the ASH Annual Meeting.
At data cut off on
The safety analysis included all 36 patients. The most common adverse event (AE) was cytokine release syndrome (CRS), which occurred in
The efficacy analysis included 25 evaluable patients at the RD. In patients with diffuse large B-cell lymphoma (DLBCL), the overall response rate (ORR) was
Prior CAR-T therapy was received by 18 patients, and 13 patients, all with DLBCL, were evaluable for efficacy. The ORR for patients with prior CAR-T therapy was
An analysis of the plamotamab exposure-response (ER) relationship from the dose-escalation portion of the Phase 1 study examined IL6 levels, CRS incidence, high-grade AEs and ORR. The ER analysis showed that during step-up dosing, the ratio of post-dose maximum plamotamab concentration (Cmax) to minimum pre-dose concentration (Ctrough) predicted CRS events, but in contrast, once the target dose was reached, there was no relationship of exposure to CRS. This analysis provides guidance for improving dosing regimens in future clinical studies of plamotamab.
Presentation Details
- Abstract 4262, “A Phase 1 Study of Plamotamab, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma: Recommended Dose Safety-Efficacy Update and Escalation Exposure-Response Analysis”
- Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III
-
Date & Time:
Monday, December 12, 2022 .6:00 - 8:00 p.m. CST -
Location:
Ernest N. Morial Convention Center , Hall D
About Plamotamab
Plamotamab is an investigational tumor-targeted XmAb® bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). CD20 is highly expressed across a range of B-cell tumors, including non-Hodgkin lymphoma (NHL). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.
Safety and anti-tumor activity from the ongoing Phase 1 clinical study has indicated that plamotamab was generally well tolerated and demonstrated encouraging clinical activity as a monotherapy. Plamotamab is also being evaluated in a Phase 2 study, in combination with tafasitamab plus lenalidomide, in patients with relapsed or refractory diffuse large B-cell lymphoma. The study consists of two parts, a safety run-in intended to establish the safety of the triple combination and a two-arm, open-label cohort where patients will be randomized to receive either the triple combination or tafasitamab plus lenalidomide.
About
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to clinical trial data for plamotamab generally, planned clinical trials, the quotations from
View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005406/en/
For Investors:
cliles@xencor.com
626-737-8118
For Media:
Evoke Canale
jason.spark@evokegroup.com
619-849-6005
Source:
FAQ
What are the results of Xencor's Phase 1 study on plamotamab?
When will Xencor present data on plamotamab?
What adverse events were reported in the plamotamab clinical trial?
What is the purpose of the plamotamab study?